Final document



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GHTF/SG2/N6R3:2002



FINAL DOCUMENT

Global Harmonization Task Force
Title: Comparison of the Device Adverse Reporting Systems in

USA, Europe, Canada, Australia & Japan


Authoring Group: Study Group 2
Date: 21 May 2002



Rita Maclachlan, GHTF Chair

The document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory agencies and the regulated industry. The document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development.
There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force.
Copyright © 2002 by the Global Harmonization Task Force

Preface

The document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory agencies and the regulated industry. The document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development.


There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force.

The purpose of this document is to provide general comparison information on the adverse reporting systems in existence in USA, Europe, Canada, Australia, and Japan. Manufacturers should refer to the current regulations and guidelines at each country or region for the reporting purposes.


GHTF Secretary's Note (June 2002): While endorsing this edition, Revision 3, to be added to the GHTF website (in place of R2), in order to recognise the total work effort involved with its development, the GHTF Steering Committee noted this version now contains outdated information. The document will not be continually updated as it was initially developed during the mid to late 1990's as a reference document to assist SG2 with its work on other Guidance Documents. The GHTF Steering Committee strongly encourages all readers to visit the Founding Member government websites to obtain information on the latest regulatory requirements for medical devices.
SECTION 1.

PURPOSE


Europe**

USA ***

Canada *

Australia

Japan

The purpose of the Vigilance System is to improve the protection of health and safety of patients, users and others by reducing the likelihood of the same type of adverse incident being repeated in different places at different times. This is to be achieved by the evaluation of reported incidents and, where appropriate, dissemination of information which could be used to prevent such repetitions, or to alleviate the consequences of such incidents.

The Vigilance System is intended to allow data to be correlated between Competent Authorities and manufacturers and so facilitate corrective action earlier than would be the case if data were collected and action taken on a State by State basis.



The purpose of the Medical Device Reporting Regulation is to ensure that manufacturers, (including those foreign), and importers promptly inform FDA of all serious injuries, deaths or malfunctions associated with marketed devices. User facilities report deaths and serious injuries. As the principal US public health agency responsible for ensuring that devices are safe and effective, FDA needs such information to evaluate the risk associated with a device in order to take whatever action is necessary to reduce or eliminate the public’s exposure to this risk.



The purpose of Mandatory Problem Reporting is to reduce the likelihood of recurrence of serious adverse incidents related to medical devices by evaluation of reported incidents and, where appropriate, dissemination of information which could be used to prevent repetitions or to alleviate the consequences of such incidents.

The purpose of the Incident Reporting and Investigation Scheme is to support the Post market monitoring processes under the Therapeutic Goods Act. Only a small, select group of high risk, registered devices are evaluated by the TGA prior to being approved for sale on the market, the majority of products being listed on the Australian Register of Therapeutic Goods without evaluation. Postmarket monitoring is considered an important process to evaluate on-going quality, safety and efficacy of therapeutic devices available in the market.

The purpose is to ensure that safety and effectiveness have been carefully evaluated before approval time, and expected adverse events and contraindications must be described on the labeling. Before the approval stage, the number of patients is restricted and only narrow ranged group of patients is involved in clinical trial. After approval, the device is used for a wide range of patients, and there is the possibility of unexpected adverse events which can not be foreseen when the device is being approved. Therefore any adverse events must be tracked to ensure safety for marketed device.

* The following information is based on the proposed regulations.


** European directive (law) and guidelines (interpretation of the directive) are not interpreted in the same way throughout Europe.

Thus reference to the directive doesn’t reflect that other requirements do exist.


*** This information represents key features of the FDA regulations and does not encompass the full scope or intention of medical device reporting requirements.
SECTION 2.

APPLICABILITY



Europe

USA

Canada

Australia

Japan

These Guidelines cover the activities of:

  • the Commission

  • Competent Authorities

  • Notified Bodies

  • manufacturers (including their authorized representatives and persons responsible for placing on the market, see Article 14 of the MDD)

  • users and others concerned with the continuing safety of medical devices

The Medical Device Reporting Regulation establishes requirements for:

  • manufacturers

  • importers

  • user facilities

Health professionals (physicians, physician assistants, pharmacists, nurses) and other consumers are encouraged to voluntarily report serious adverse events and product problems.





The Medical Devices Regulations cover the activities of:

  • Medical Device Bureau

  • Bureau of compliance and Enforcement

  • Manufacturers

  • Distributors

The Therapeutic Goods Act cover the activities of:

  • The Therapeutic Goods Administration

  • Manufacturers

  • Sponsors (manufacturers and importers)

Postmarket reporting of adverse events is mandatory for device sponsors when they become aware of a serious injury or death involving a device.


A device sponsor is generally the legal entity which manufactures or imports a therapeutic device.
Postmarket reporting of adverse events is voluntary , but strongly encouraged, of healthcare institutions or practitioners.

These Guidelines cover the activities of:

  • MHW (Ministry of Health & Welfare)

  • Medical facility (voluntary)

  • Manufacturer/Importer/Domestic agent for foreign manufacturer


SECTION 3.

REPORTING TIMING


Europe

USA

Canada

Australia

Japan

Section 3.1

MANDATORY REPORTING



Section 3.1

Section 3.1

Section 3.1

Section 3.1

The report should be made as soon as possible. The time given below is the maximum elapsed time for determining the relevant facts and making an initial report. The time runs from the manufacturer first being informed of the incident, to the relevant Competent Authority receiving the notification from the manufacturer.

Incidents: 10 days

Near incidents: 30 days


Adverse event report: the time from the date the manufacturer or user facility became aware of information that reasonably suggests that a device has or may have caused or contributed to the event to the date of the report.

  • Manufacturer

Death, serious injury, reportable malfunctions: to FDA within 30 calendar days

  • User facility

Death: to FDA and manufacturer within 10 working days

Serious injury: to manufacturer within 10 working days. (Such reports shall be submitted to FDA if the device manufacturer is not known)



  • Distributor

Death, serious injury, and malfunctions: to manufacturer within 10 working days

Death, serious injury to FDA within 10 working days



Manufacturer 5-Day Report: the time runs (in working days) from the manufacturer became aware that a reportable MDR event necessitated remedial action to prevent an unreasonable risk of substantial harm to the public health to the date of the report;

or becoming aware of a reportable event for which FDA has made a written request for the submission of a 5-day report. When such a request is made, the manufacturer shall submit, without further requests, a 5-day report of all subsequent events of the same nature that involve substantially similar devices for the time period specified in the written request.

Manufacturer Baseline Report: to be submitted for a device when the device model is first reported and to be updated annually on the anniversary month of the initial submission (Pending Guidance)


Manufacturers and Importers must report within the following time period the device related adverse events to the Bureau of Compliance and Enforcement.

Incident: 10 days

Near incident: 30 days


Reporting times are not specified, but are predicated on the phrase “…as soon as possible after the sponsor becomes aware…”

Medical Device manufacturers, importers and domestic agents for foreign manufacturers report within the following time period to the Safety Division of MHW after they become aware of an event:

  • Unlabeled serious incidents or near incidents – 15 days

  • Labeled serious incidents or near incidents – 30 days

  • Unlabeled medium level incidents or near incidence – 30 days

  • Serious incidents by infectious diseases that could be caused by using medical devices – 15 days.


SECTION 4.

REPORTING CRITERIA


Europe

USA

Canada

Australia

Japan

Section 4.1

DEATH/SERIOUS INJURY



Section 4.1

Section 4.1

Section 4.1

Section 4.1

Death or

Serious deterioration in state of health:



Death, or

Serious injury, which means an injury or illness that:



  • Is life threatening

  • Results in permanent damage to a body structure

  • Results in permanent impairment of a body function

(Permanent means irreversible, but not trivial, impairment or damage to a body structure or function.)

Death or

Serious deterioration in state of health:



  • Life threatening

  • Permanent damage to a body structure

  • Permanent impairment to a body function

Death or

Serious injury, is not specifically defined, but is taken to be:



  • Life threatening

  • resulting in permanent damage to a body structure

  • resulting in permanent impairment of a body function.

Death or

Serious injury means an injury or illness that:



  • Is life threatening

  • Results in permanent damage to a body structure

  • Results in permanent impairment of a body function




Section 4.2

CONDITIONAL SERIOUS INJURY



Section 4.2

Section 4.2

Section 4.2

Section 4.2

A condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent impairment of a body structure.

An injury or illness that necessitates medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.


Condition which necessitates medical or surgical intervention to prevent:

  • Permanent damage to a body structure

  • Permanent impairment to a body function

Conditional serious injury is not specifically defined, but is taken to be:

  • An injury requiring clinical intervention to prevent serious injury.

Condition which necessitates medical or surgical intervention to prevent:

  • Permanent damage to a body structure

  • Permanent impairment to a body function

Section 4.3 Malfunction

Section 4.3

Section 4.3

Section 4.3

Section 4.3

All reportable adverse events require there to have been a malfunction or deterioration in the characteristics and/or performance of a device which led to or might have led to death or a serious deterioration in health. Where no serious injury/death occurred, it is sufficient that if the event occurred again in might lead to death/serious deterioration in health and is known as a near incident.


Device malfunction (or failure to meet performance specifications or otherwise perform as intended) such that the device or a similar device would be likely to cause a death or serious injury if the

malfunction were to recur.



  • Performance specifications include all claims made in the labeling for the device.

  • Intended use may be shown by labeling claims; advertising matter; oral or written statements.

A malfunction is considered likely to cause or contribute to a death or serious injury if:



  • the chance of it causing such an event is not remote or minute

  • it affects the device in a catastrophic manner that may lead to a death or serious injury

  • the manufacturer takes or would be required to take action to prevent a hazard to health as a result of the malfunction




  • a malfunction of the same type has actually caused or contributed to a death or serious injury in the past two years.




Malfunction or deterioration in the characteristics and/or performance of a device which might have led to death or serious deterioration in health:

  • incident occurred and

  • is such that if it occurred again, it might lead to death or serious deterioration in health




Malfunction is not specifically defined, but is taken to be:

A failure of the device to perform as expected which has the potential to compromise patient or operator safety.

Such a failure may be caused by design, excessive claims, specification or labeling or device/component failure in which the device/system did not fail-safe.


Failure, malfunction, improper/inadequate design, manufacturing problem and improper/inadequate labeling which has led or may lead to death or damage if malfunctions re-occurs.


Section 4.4

USER ERROR



Section 4.4

Section 4.4

Section 4.4

Section 4.4

User errors are generally outside of the adverse reporting system except when;

  • Examination of the device or labeling (inaccuracies in the instruction leaflet or instruction for use include omissions and deficiencies) indicated some factors which could lead to an incident involving death or serious deterioration in health.




  • Use error (errors induced by poor design, poor labeling, poor instruction, etc. which could lead to an incident involving death or serious injury).




  • Examination of the device or labeling (inaccuracies in the instruction leaflet or instruction for use include omissions and deficiencies) indicated some factors which could lead to an incident involving death or serious deterioration in health.




User error is not specifically defined, but is taken to be:

  • A situation where patient or operator injury, or near injury, is caused by incorrect use, i.e. not following instructions or labeling when these are assessed as adequate for a “normal” or “reasonable” user.

  • “Off label” use when either the device is not specified for the application or specifically contra-indicated within the instructions for use or labeling.

  • Recall provisions address inadequate labeling which could lead to an incident involving death or serious injury. There are no such definite provisions in adverse incident reporting.



Section 4.5

LITERATURE ANALYSIS



Section 4.5

Section 4.5

Section 4.5

Section 4.5

No such guideline exists and the EU Vigilance guideline states “These guidelines make no recommendations on the structure of the systems by which manufacturers gather information concerning the use of devices in the post production phase”. However, the directive indicates that “The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from device in the post production phase”.

Reporting is required when the manufacturer becomes aware of a reportable incident regardless of its source such as literature reports.


The Regulations do not specify how the manufacturer or importer becomes aware of reportable incidents, but simply that they must report them within certain time limits based on when they become “aware”.

The Therapeutic Goods Act does not specify how a sponsor becomes aware of reportable events, but conditions imposed under the Act require that” Where the goods are distributed overseas as well as in Australia, product recall or any similar regulatory action taken in relation to the goods outside Australia which has or may have relevance to the quality safety or efficacy of the goods distributed in Australia must be notified.. immediately the action or information is known to the sponsor”.

Research literature which indicates the following items:

  • serious effect to human health

  • great change of the trend of adverse events

  • no effectiveness




Section 4.6

REMEDIAL ACTION



Section 4.6

Section 4.6

Section 4.6

Section 4.6

Not applicable

5-Day Manufacturer Report means a report submitted upon:

  • becoming aware that a reportable event or events, necessitates remedial action to prevent an unreasonable risk of substantial harm to public health; or

  • becoming aware of a reportable event for which FDA has made a written request for the submission of a 5-day report. When such a request is made, the manufacturer shall submit, without further requests, a 5-day report for all subsequent events of the same nature that involve substantially similar devices for the time period specified in the written request.

Not applicable

Not applicable

Not applicable

Section 4.7

VOLUNTARY REPORTS



Section 4.7

Section 4.7

Section 4.7

Section 4.7

Voluntary reports may be submitted at any time and may be other than death, serious injury or malfunction as defined.

Voluntary reports may be submitted at any time and may be other than death, serious injury or malfunction as defined.

Voluntary reports may be submitted at any time and may be other than death, serious injury or malfunction as defined. Reports of incidents (including those involving death or serious deterioration in health) from those other than manufacturers and importers (for example, hospitals, coroners, the public, etc.) are also considered voluntary reports.

Voluntary reports may be submitted at any time and may be other than death or serious injury.

Voluntary reports may be submitted at any time and may be other than death, serious injury or malfunction as defined.

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